Mitralign Percutaneous Annuloplasty System Shows Improved Valve Function at 6 Months

June 1, 2015—Mitralign Inc. announced that 6-month data on the Mitralign percutaneous annuloplasty system (MPAS) for the treatment of functional mitral regurgitation (FMR) were presented by Prof. Georg Nickenig, MD, at the 2015 EuroPCR annual meeting held May 19–22 in Paris, France.

According to Mitralign, the prospective, multicenter, single-arm study met its safety endpoint at 30 days and its performance endpoint at 6 months. The MPAS demonstrated a statistically significant reduction in left ventricular diameter, significant reduction of both the anterior–posterior and septal–lateral annular dimensions, and a significant improvement of the patient’s walking distance. Enhanced ventricular function was demonstrated by significant improvement in left ventricular end diastolic diameter and left ventricular end diastolic and systolic volumes.

The company noted that the study was composed of a very challenging FMR patient population. All patients were on optimal medical therapy and had an average ejection fraction of 33%. The MPAS is not approved for sale or distribution; however, it is anticipated to receive European CE Mark approval in 2015.

Prof. Nickenig, who is from the University of Bonn in Bonn, Germany, commented in the company’s press release, “The data show statistically significant progress at 6 months, specifically in ventricular remodeling which is one cause of patient symptoms. These encouraging data further support the use of percutaneous valve repair to treat this challenging patient population.”

The company also noted that it aims to treat tricuspid regurgitation using the same technology as used with FMR, but with a modified delivery system. At EuroPCR, Prof. Joachim Schofer, MD, discussed his successful use of Mitralign’s MPAS to perform a direct transcatheter annuloplasty on special access patients with tricuspid regurgitation.

In March, the company announced that a detailed report of the first successful case of a direct transcatheter tricuspid repair for severe tricuspid regurgitation was published by Prof. Schofer, et al in Journal of the American College of Cardiology (2015;65:1190–1195). Prof. Schofer is from the Medicare Center and Department for Percutaneous Interventions of Structural Heart Disease at Albertinen Heart Center in Hamburg, Germany.